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BOLAR RECALLS FOUR PRODUCTS, CITING MANUFACTURING DISCREPANCIES

Executive Summary

BOLAR RECALLS FOUR PRODUCTS, CITING MANUFACTURING DISCREPANCIES for three of the products and the possible substitution of a brand-name drug in the biotesting for ANDA approval of one product. Announced by Bolar July 26, the recall extends down to the retail level. The three products recalled for manufacturing problems are methylclothiaside with deserpine 5 mg/0.25 mg, ergoloid mesylate 1 mg oral tablets and pentaerythritol tetranitrate SR tablets. The product being recalled for suspected fraud is meclofenamate sodium. Bolar said that the products represented 5% of company net sales in 1989 and 16% of pre-tax income. The recall adds to the woes of the company, which shut down its manufacturing and shipping operations in March ("The Pink Sheet" March 12, T&G-1) after recalling a total of 16 products, explaining that it could not assure bioequivalence due to discrepancies in manufacturing or ANDA applications ("The Pink Sheet" Feb. 19, p. 12). The manufacturing discrepancies were discovered during independent audits of the company's applications and manufacturing processes. Bolar determined that the "drugs were not manufactured in accordance with FDA approvals and/or that the company's records do not accurately reflect the composition and/or processes by which these drugs or batches thereof were manufactured," the firm's release states. At least one of the drug components, deserpine, was found to contain raw material from an unapproved source. Meclofenamate is the third Bolar drug, after nitrofurantoin (Norwich Eaton's Microdantin) and thioridazine (Sandoz' Mellaril), for which a substitution of the brandname product during biotesting may have occurred. In the release, Bolar stated that the "test results on the drug meclofenamate sodium, which were necessary for FDA approval, can no longer be considered as reliable." Testing of the original biosamples "indicates that the Bolar imprinted capsules may have contained material manufactured by the brandname company against which the Bolar product was compared." In addition to the recalls, Bolar said it is discontinuing manufacture of 14 products for "economic reasons" (see chart). The company said that it chose to discontinue the products when it found it would be too costly to audit the original ANDAs and perform new biostudies for resubmission to FDA. The products accounted for approximately 6% of Bolar's 1989 net sales and 16% of income before taxes. Bolar has begun submitting applications to FDA for reapproval as products emerge from the independent audit process. The company said that it "expects to continue to file additional reapproval requests from time to time, [although] there can be no assurance as to the receipt of any such approvals nor as to the timing thereof." Bolar has renegotiated severance pay arrangements made with former company President Robert Shulman and former Exec-VP Jack Rivers. When the execs resigned in February, following evidence of wrongdoing, Bolar agreed to continue payment of full salaries for two years. The renegotiated agreement terminates payments as of July. However, Schulman and Rivers, founders of the company, still retain 5% and 10% of Bolar stock, worth $5.9 mil. and $11.7 mil., respectively.

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